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spk00: Good morning, ladies and gentlemen, and welcome to Impel Pharmaceutical's third quarter 2022 earnings and business update conference call. At this time, all participants are in a listen-only mode. Later in this call, a question and answer session will be conducted and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded, and now I would like to turn the conference over to Impel's Chief Financial and Business Officer, Dr. John Lehman. Please go ahead.
spk01: Thank you, Chris. And good morning, everyone. We are delighted that you could join us today for MPEL Pharmaceuticals Quarterly Earnings Conference call to review our third quarter 2022 commercial and financial results, as well as to provide a general business update. Joining me from MPEL this morning is Adrian Adams, MPEL's Chairman of the Board and Chief Executive Officer, and Lynn Palillo, Chief Commercial Officer. Before we begin, I would like to remind everyone that we have a slide presentation to accompany our conference call this morning, which can be viewed at our website at www.impelfarma.com. If you are listening to this call on your telephone, you may access a synchronized slide deck on our website by choosing the link on our webcast page that says click here to listen. Moving the slide to forward-looking statements, I'd like to remind you that during the call, the company will be making forward-looking statements that are subject to risks and uncertainties, that may cause actual results to differ from the results discussed in the forward-looking statements. With that, I will turn the call over to Adrian Atkins. Adrian?
spk05: Thank you, John, and good morning, everyone, and thank you all for joining us. I am pleased, as always, to update you on the commercial and corporate progress we have made in quarter three and year-to-date 2022. The agenda for today's call can be seen on our next slide, slide number three. During this call, we will provide a prescription performance update for Trudesa in addition to covering ongoing prescriber, market access, and patient dynamics data for the third quarter and year-to-date 2022. We will then briefly review our financial performance in addition to providing a status update on the market and clinical development opportunity with IMP 105 for the treatment of autism. I will then present an overall summary and an outlook for the business going forward before opening the call up for your valued questions. With this said, let's turn to slide number four to begin our commercial performance review with Tradesa. As you can see on this slide, Tradesa has continued a consistent and positive launch trajectory with sustained quarter-over-quarter growth in total prescriptions. The 27% increase in prescriptions from quarter two to quarter three comes as we completed the expansion of our Salesforce footprint from 60 to 90 sales professionals in late July. We are delighted that cumulative total prescriptions since launch have now reached close to 50,000, with this growth highlighting the clear unmet need that persists for people with migraine, patients who need predictable, consistent, and well-tolerated pain relief, a profile that can be delivered with Trudesa. Turning now to our next slide, slide number five. We're also pleased to see that the average weekly symphony NTRX numbers for Trudesa increased from an average of 1,245 per week in August to close to 1,500 per week in October. We believe that this inflection in performance is a direct result of our field force expansion with all lead performance indicators relating to new prescribers, new patient starts, and consistently high referral rates, all moving in a positive direction. On the right-hand side of this chart, you will note that the Tredesa market share is now over 5% within the acute branded market among prescribers. This, just 12 months into the launch of the product. Please now refer to slide number six, where we will take a closer look at the encouraging early signs related to the clear impact of our Salesforce expansion. New prescriptions, the key to continued product growth, increased by 45% versus the second quarter, signaling a significant acceleration. On the right-hand side of the slide, you will note we also saw another sizable jump in normalized new Rx's from September to October as we moved into the fourth quarter of this year. Importantly, these clear productivity gains from the Salesforce expansion go beyond just the number of reps deployed. With this in mind, please refer to our next slide, slide number seven. As you will see, we have seen an acceleration of new prescription growth across both new and existing territories. In September, only the second month After our expansion was complete, our original 60 territories saw normalized new prescriptions increase 53% compared to the average monthly new patient totals in the second quarter of 2022. At the same time, our 30 expansion territories surged by 38%, again, only two months after hitting the field. The smaller territory sizes that resulted from our Salesforce expansion amplified or targeted approach leads to greater efficiency and higher reach and frequency across all target segments and allows for significant increases in peer-to-peer education opportunities. Turning now to slide number eight. On this slide, I would like to highlight the 30% increase in new prescribers when comparing August to October, the three months post-Salesforce expansion, to the previous three months. We're delighted that we have now crossed over 2,000 unique prescribers since launch, and it is also worthy of note that since our launch in October 2021, only 64, or 3%, of Trudesa prescribers have lapsed, meaning they have gone longer than eight weeks without another new prescription, an impressive retention rate compared to other product benchmarks in this space. We believe this loyal prescribing comes from strong sales execution a smooth prescribing experience for healthcare professionals, and most importantly, rapid, consistent, and sustained pain relief for patients. Please now refer to next slide, slide number nine. The evolution of our net price continues, driven by the increasing percentage of reimbursed prescriptions with Tradesa. This now reaching close to 60% versus 53% and 54% in the first and second quarters respectively. This consistent progress supports our view that Tradesa is a sustainable growth and value-generating asset. Moving to the right-hand side of this slide, the refill rate with Tradesa has remained both consistent and high, averaging 63% since launch. This is impressive, and we believe, again, reflects high patient satisfaction and signals that patients are using Tredesa for more than the occasional severe migraine. Turning now to our next slide, slide number 10, I would like to share some qualitative data collected directly from current Tredesa patients. These data are consistent with feedback we have received from previous patient research, and importantly, with the clinical results seen in our pivotal Stop 301 Phase 3 study. Indeed, our confidence in the potential for Tredesa is rooted in the belief that we are changing and improving the lives of those suffering from migraine. When surveyed on key product benefits such as rapid onset, consistent pain relief at two hours, tolerability, and ease of use, patients reported very high satisfaction scores between 80 to 87%. When comparing Tredesa to their previous therapy, 67 to 74% of patients agreed or strongly agreed that Tradesa is more convenient, better tolerated, faster working, and more effective during a migraine compared to their previous therapy. We have maintained that despite new options for those suffering from migraine, patients and physicians are still in search of efficacy, And in light of the patient data we have just shared, the opportunity for continued significant growth for Tredesa comes into view. Please refer now to slide number 11. Symphony data continues to show that a very high percentage of patients, around 60%, drop off or switch away from GPAS, and more specifically, NERTEC and UBrelvit, at some point in therapy. Given the tolerability of these products, it is our contention that the primary reason for this continued turnover with GPATs is that prescribers are not finding the rapid, sustained, and consistent efficacy they're looking for in acute migraine treatments. This turnover in the market opens up a large pool of eligible patients, and more specifically, a significant ongoing opportunity for Tredesa. Looking at the right-hand side of the slide, you can see that while TUDESA does draw from a broad pool of patients, GPATs represent the most common previous therapy. Whether replacing a previous therapy or used in addition for specific attacks, we believe physicians are increasingly filling an efficacy void with TUDESA. With that, I will now turn the call over to John to review our financial results for the third quarter of 2022. John? Thank you, Adrian.
spk01: On our next slide, slide number 12, you will see our financial results for the third quarter of 2022. The net product revenue for the third quarter of 2022 was $3.1 million versus $0.1 million for the same period in 2021. Initial shipments of Trudessa to specialty farm disease began in September of 2021 ahead of the October commercial launch. Research and development expenses for the third quarter of 2022 were $3.2 million versus $5.9 million for the same period of 2021. The decrease was primarily due to reduction in Tradesa clinical expenses as the Phase 3 study was closed, partially offset by an increase in spend for the clinical development of INOP 105. Selling general and administrative expenses for the third quarter of 2022 were 19.7, which compares with 16.3 for the same period of 2021. The increase in SG&A was due primarily to the ramp-up in spending to support the commercial and marketing activity for Tradesa launch. Turning now to slide 13, for the third quarter of 2022, Impel reported a net loss of $31.1 million, or $1.31 per common share, compared to a net loss of $25 million, or $1.24 per common share, for the same period of 2021. As of September 30, 2022, the company had cash and cash equivalents of $79.7 million. With that, I would like to now turn the call back over to Adrian to make some additional closing remarks. Adrian?
spk05: Thank you, Joel. Before closing, I did want to make a few remarks on the market opportunity and projected timings with IMP 105, a product we are developing for the acute treatment of agitation and aggression in autism. This next slide, slide number 14, provides some background on this autism market opportunity. The unmet need is large and only continues to grow as the incidence of autism spectrum disorder, or ASD, increases. According to our research, approximately 600,000 children with ASD display episodes of agitation or aggression. The impact on the children, their families, and caregivers of the over 100 million episodes annually is significant, and effective treatment options with favorable safety and tolerability profiles are desperately needed. This is the unmet need opportunity for IMP 105. Turning now to slide number 15. IMP 105, for those of you who may not be aware, is a proprietary formulation of olanzapine specifically designed for rapid absorption at the nasal administration. The formulation is designed to be administered as a single spray administered from our dry powder pod device to the upper nasal space. In CALM 101, a Phase 1B clinical study with IMP 105, Impell administered 5 mg, 10 mg, and 50 mg doses of IMP105 and compared the plasma levels and pharmacodynamic effect to an intramuscular injection of olanzapine, or IM, and placebo. IMP105 demonstrated similar plasma exposure levels on a dose-for-dose basis, but was faster to reach peak levels compared to IM. IMP105. demonstrated onset within 15 minutes with similar or greater effect compared to placebo or IM. IMP105 was well tolerated at all dose levels. We recently initiated a Phase IIa proof of concept, two-way, two-period crossover, double-blind study, the CALM201 study, to evaluate the safety and efficacy of IMP105 as an acute treatment versus placebo in adolescents with ASD experiencing agitation. Approximately 32 patients with ASD who are currently being treated for agitation aggression at two inpatient units specializing in behavioral treatment are being enrolled. Impell will be observing safety as well as utilizing multiple scale to measure agitation reduction after a five milligram dose of IMP-105. EMPL expects to complete a pilot phase of the study consisting of the first six patients in this final quarter of 2022. This pilot phase will evaluate safety and study feasibility prior to further enrollment. Full study results are expected in the third quarter of 2023. With that, I would like to turn to our final slide, slide number 16, which summarizes our call today. Impel Pharmaceuticals continues to execute against our key value drivers, with quarter over quarter NTRX growth of 27%. Our prescriber base has increased by 30%, and just one year into our launch, we have drawn depth to over a 5% share of the acute branded market within that group. Importantly, the investment we made in our field force expansion is showing rapid results, with a 45% increase in new prescriptions and efficiencies seen across both new and existing territories. Our thoughtful managed care contracting and novel distribution network position us to make strategic and measured adjustments to our Quick Start program over the coming quarters. These adjustments are designed to ensure patient access while evolving our net price in a meaningful and value-added way. On the development front, we are pleased with the progress of the CAM201 study and the potential for IMP105 to have a major impact on children and families looking for a trusted at-home and as-needed treatment for children and adolescents on this autism spectrum coping with agitation. And finally, in addition to a continued focus on disciplined execution, we are currently assessing a number of financing and strategic opportunities in line with increasing shareholder value over time. Thank you, and we will now open the call to your value questions. Operator, can you please give the instructions?
spk00: Yes, thank you. To ask a question, you'll need to press star 1 1 on your phone. Please stand by as we compile the Q&A roster. One moment please for our first question. Our first question will come from Ken Cacciatore of Cowan. Your line is open.
spk03: Hey, Adrian, John. Thanks for the question. You know, what's fascinating to me is going back to slide 11 when you talk about add-on. It's certainly, as we speak more and more with our clinician consultants, they have a real desire to write it, true to us, so simultaneous with the GPANs. They really want to have this available as a rescue is what they often tell us. So just wondering, one, can you just elaborate on kind of the evolution of that? I think the first time you're showing a slide like that, which is very helpful. And then, two, can you talk about managed care, willingness, or where you sit on the formulary to be able to be written simultaneous with another brand? And then also, we did see a little bit of a degradation in the value per Rx. Just wondering, is it supporting that new kind of the Salesforce push here? Is there more sampling? If you could kind of address that as well. Thanks so much.
spk05: Okay, Ken, thank you very much for your questions. I'll address the first point. I think you're absolutely correct. I think one of the data points that we continually review is what the source of business is for traditional. I mean, given its efficacy and tolerability profile, we anticipated that physicians would start to use and get experience with the product and post-GPANT failures. What we've been very encouraged to see, and this is all we predicted in this marketplace, is that given this profile, and in particular, given this very high level of churn over with GPANT, Neurotech and Ubrella in this market, that indeed the product is being used not only in patients who failed triptans, who need that extra efficacy and tolerability, but being used alongside those products as well. In addition, we are increasingly starting to see the product being used ahead of GPAMs as well. So this evolving profile just puts into perspective in relation to the opportunity with 2DS. So I'm very pleased that you're getting that feedback from from physicians, and it's totally in line with both the qualitative and quantitative feedback that we are getting from within the marketplace. On your next points in relation to managed care and value for prescription, I'm going to ask Len to comment on those, please. Len?
spk04: Thanks, Adrian. Ken, most of our contracts are rather silent on the use of Shudessa with other, you know, branded abortive medications. When you talk to clinicians, as you have, that is the best practice. It's called the toolbox approach. And most managed care plans are silent on it and therefore not restricting the ability to have TREDESA added on as a rescue when needed to a patient that's using NERTEC or UBRELTI as their base therapy. As Adrian said, I think what you see some patients getting TREDESA prior to a GPANT, depending on, you know, that patient dynamic. But to date, you know, where we do have any issues at a local level, we've had very good KOL support in addressing that utilization management to ensure that patients have access to what they need. On the net price piece, I think you kind of hit on it. The blend of new patients in Q3 was significantly higher as a proportion of prescriptions versus Q2. And the QuickStart programs are really designed for that smooth prescribing experience to get patients on drug quickly. So for example, if a physician writes a prescription on Tuesday and we wait for that physician to complete a PA and for the plan to adjudicate, sometimes that's just too long for the patient. So we will often ship a quick start prescription to make sure the patient doesn't abandon it, that they get the relief that they need. So that higher blend of new patients because of the Salesforce expansion led to a higher utilization of quick start in Q3.
spk03: Great, thanks so much.
spk04: Thank you, Kelly.
spk00: Thank you. As a reminder, to ask a question, please press star one one on your phone. One moment for our next question. And our next question will come from Zaman Nasir of Wedbush Securities. Your line is open.
spk02: Hi, everyone. This is Zaman on for Laura Chico from Wedbush. I was wondering if you could comment on refill rates during the third quarter and what are your expectations heading into 2023 in terms of how this might change and what are some of the drivers impacting refill rates here? And kind of related to this, what do you envision as the next big drivers for inflection into desert prescribing?
spk05: Yeah, thank you very much for the question. I think one of the things that we've been very pleased with right from the first month of the And as we mentioned, I think we're now almost one year into the launch. The refill rate has been consistently high at that kind of 60 to 65% level. So clearly, I think if one looks at the most recent data within the quarter, around about the kind of 63% level. And if you compare that to most benchmarks at this stage of a product's launch, that is a very high refill rate. And clearly we always see this as being a very important measure because clearly that's a direct, sorry, an indirect kind of manifestation of patients' satisfaction. So clear, and by the way, that is totally consistent with the results of our phase three studies. So moving forward, I think we anticipate that as the product gets more and more established and used, that refill rate is going to be maintained. over the course of time. And clearly, I think, given the efficacy and tolerability profile, that certainly is not a surprise to us. But clearly, it's very good to be able to see that within the overall marketplace. So again, we see that as being rock solid moving forward. And on the second part of your question, I'm going to ask Len to comment on that.
spk04: Sure. In terms of catalysts and inflections going forward, our field force expansion is really just starting to show the benefits. As you heard Adrian talk about, it was a pretty rapid impact. But still, as we sit here in November, the new reps really only have about three months in territory. And so as they are continuing to get appointments booked and continuing to expand their reach and the depth of their frequency, that coupled with what we anticipate to be further investment in awareness-generating activities Like, very targeted non personal work as well as in the coming quarters. We think those are all going to pay large dividends. 1 more comment on the refill rate. As Adrian said, we do expect that to continue to. To stay to stay steady throughout 2022, even as pods per prescription. have increased to approximately six. We've not seen any change in refill rates, leading us to believe that patients are using that drug, getting good relief, and will continue to refill.
spk05: Thank you, Len. And obviously, I think Len commented there on the kind of, again, the expansion of the sales force. And clearly, I think we anticipated this. But we always anticipated that the third and fourth quarter of this year would be a very important kind second half of the initial launch period. So clearly the dynamics in this marketplace were not only are we increasing the number of prescribers, but also the new patient increase, I think, as a direct result of the expansion. We're very, very pleased with that. Not only from the fact that obviously the platform that it creates for moving into 2023 creates a very strong platform for growth.
spk02: Great. Thank you.
spk00: Thank you. Again, to ask a question, please press star 1 1 on your phone. One moment, please, as we compile the Q&A roster. I am seeing no further questions in the queue. I would now like to turn the conference back to Adrienne Adams for closing remarks.
spk05: Okay, well, thank you very much, everyone, for joining us. It was our pleasure to have this call, and we look forward to updating you on our continued progress throughout the remainder of this year as we continue to create value for patients, healthcare professionals, and you, the shareholders we serve. Thank you so much.
spk00: This concludes today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day. The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1.
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